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cap-ONE

FDA UDI

Class I (US FDA UDI)

by Nihon Kohden Corp.

Identity

Trade Name
cap-ONE FDA UDI
Generic Name
Carbon dioxide monitor FDA UDI
Device Name
cap-ONE Nasal Adapter, Adult, w/ Oxygen tube FDA UDI
Model / Reference
YG-221T FDA UDI
Description
cap-ONE Nasal Adapter, Adult, w/ Oxygen tube FDA UDI

Identifiers

Catalog Number
YG-221T FDA UDI
Primary DI / UDI-DI
14931921010270 FDA UDI
FDA Product Code
BZA FDA UDI
CAT FDA UDI
GMDN Term
Carbon dioxide monitor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5810 FDA UDI
868.5340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Carbon dioxide monitor

cap-ONE by Nihon Kohden Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbon dioxide monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nihon Kohden Corp.

Sources (1)

  • FDA UDI 4c45e3af-2b8a-4f4a-a7d5-ddd5346e4c3b 34 fields · synced May 30, 2026